With clinical governance beginning to bite, most trusts still seem unready for the cultural changes needed, write Kieran Walshe and colleagues

It is now three years since the government launched its NHS quality reforms.

1In that time, we have seen the setting up of two major new national organisations, the National Institute for Clinical Excellence and the Commission for Health Improvement, and the establishment of new systems and responsibilities for clinical governance.

The Health Act 1999 has created, for the first time, a statutory duty of quality for healthcare organisations and those who lead them.

Arguably, the NHS is doing more to manage and improve quality than ever before.

Yet at the same time, public confidence in the quality of care provided by the NHS seems to be lower than it has ever been, because of a series of high-profile scandals and service failures. To the public, the NHS appears to have a closed and protective professional culture in which quality problems are ignored or covered up, clinicians are not accountable for their clinical standards, and the interests of clinicians and providers are put before those of patients.

Clinical governance is at the centre of the NHS quality reforms. It is crucial in dealing with the quality failures and problems of the past.

2Itinvolves establishing clear lines of responsibility and accountability for quality in NHS organisations, putting a comprehensive programme of quality improvement activity in place, and having robust arrangements for identifying and remedying risks and poor performance.

But, more than that, it is generally accepted that clinical governance demands a major shift in the values, culture and leadership of the NHS, to place greater focus on the quality of clinical care and to make it easier to bring about improvement and changes in clinical practice.

2But all this is easier to say than it is to do. Mandating the development of quality improvement structures and processes in healthcare organisations, through central policy directives or legislation, has not been especially successful in the past either in the UK or in other countries.

4Successful quality improvement demands major cultural change - but that change cannot simply be imposed, as it entails a significant shift in the way that people think and behave. Equally important, it requires a realignment of incentives and other policy priorities, which otherwise may cut across or conflict with the aim of quality improvement. There is no doubt that the implementation of these reforms is high on the policy agenda, but is that enough to make them happen?

Researchers at Birmingham University have been tracking the development of clinical governance at all 47 trusts in the region since early 1999, as part of an NHS Executive-funded research project. We have used a combination of surveys, document reviews, visits, and face-to-face and telephone interviews with senior managers and clinicians to examine how implementation is proceeding, and whether first indications suggest that the process of transforming policy into practice is on course (see box 1).

5First steps All trusts in the West Midlands have made progress in implementing clinical governance, and their actions so far have been focused on meeting the national guidance from the NHS Executive and the regional guidance provided by the regional office.

They have begun by setting up clinical governance committees, writing strategies and appointing clinical governance leads.

These actions, though undoubtedly necessary, do not of themselves mean that real progress is being made towards clinical governance. The agenda now needs to move on, from putting systems and processes in place, to making them work and demonstrating that they do.

There is almost universal agreement that clinical governance requires a major cultural change in the NHS, and the direction of that change is widely supported.

But our research found few signs that such a cultural transition was starting to take place, and little evidence that trusts were taking explicit actions aimed at stimulating such a change.

Cultural change is notoriously difficult to effect in any planned way, but it seemed that the focus of actions so far on clinical governance was not addressing the cultural and organisational dimension.

If there is one consistent message from the wider literature, it is that the successful implementation of clinical governance depends on leadership - both clinical and managerial. We found encouraging evidence that NHS boards and their members were taking their responsibility for quality more seriously, and that some impact on board processes and decisions could already be discerned.

But we also noted that those responsible for leading clinical governance - particularly chief executives, medical directors and nursing directors - already had immensely demanding and difficult jobs of which clinical governance was just one component.

We were not convinced that those leading clinical governance in trusts were investing sufficient time and attention to translate their undoubted personal commitment into an organisational or corporate commitment.

Most trusts already make a substantial investment in clinical quality improvement. They have support staff for functions such as clinical audit, risk management, complaints, and so on, committees and groups at trust level for many such functions, and they often replicate those systems at directorate or departmental level. This investment of time, money and managerial and clinical effort is frequently fragmented, and may not be used very effectively. While many trusts identified the availability of resources as a likely constraint on the development of clinical governance, few were undertaking a root and branch review of their existing investment to make it work better.

During our research trusts were just starting to move from focusing on clinical governance at a trust level, to thinking about and putting in place structures and processes closer to the clinical work face, in directorates, departments or service areas. We found little actual progress had yet been made in this area, which we believe should be a priority for the future.

There is an urgent need for good measures of progress in clinical governance, which can inform at an organisational level but also be used to track progress and identify areas where some action or support is needed.

In an earlier survey of trusts, we collected a range of structural data about the progress of clinical governance, which has the virtue of being available and measurable but which tells us little about the real functioning of clinical governance. We believe that measures which are based on assessments by other stakeholders, and data gathered directly from people working within an organisation may offer better and more meaningful assessments of the progress of clinical governance.

The NHS Executive in the West Midlands undertook clinical governance reviews in all trusts, using a site visit by a review team drawn from the regional office and from other trusts. This gave us an opportunity to explore the impact of this kind of process, which has much in common with many existing review or accreditation mechanisms and with the clinical governance reviews which are being introduced.

We found that the programme of clinical governance reviews was viewed as constructive and helpful by most trusts, and that it certainly had some impact on the progress of clinical governance. However, there were substantial costs as well as some benefits, in that the reviews involved comprehensive preparation and diverted attention from other important issues.

A more focused and targeted approach to review, which took more account of the individual organisation's context and characteristics, might be more effective at producing lasting change.

It is too early to discern much real impact from the NHS quality reforms in general, or from clinical governance in particular. While there is little tangible evidence that clinical governance is making a difference yet, we were encouraged by some early signs that NHS boards were taking quality issues more seriously. And that quality problems were less likely to be allowed to persist and more likely to be tackled (see box 3).

Our research suggests that some important progress in implementing the quality reforms has been made in the last three years, and that many of the structures and systems needed for effective clinical governance are now in place.

But it seems that clinical governance has yet to make a real difference at the clinical workface, and that the changes in culture that it demands of healthcare organisations have not really begun to happen yet. This is not surprising - these sorts of changes will take time.

However, if they are to be achieved, there has to be sustained and consistent support for clinical governance from policy-makers and from NHS boards. Our research is now continuing, with some further work focusing on a small number of case study organisations and on how best to measure the progress of clinical governance, and plans for some research in primary care organisations.

1Department of Health. The New NHS: modern and dependable. London: HMSO,1997.

2 NHS Executive. HSC 1999/065. Clinical Governance: in the New NHS. Leeds: NHS Executive,1999.

3 Scally G, Donaldson LJ (1998). Clinical Governance and the Drive for Quality Improvement in The New NHS in England. Br Med J,3 1 7:61-65.

4Walshe K (ed). Evaluating Clinical Audit: past lessons, future directions. London: Royal Society of Medicine,1995.

5 Latham L, Freeman T, Walshe K, Spurgeon P, Wallace L. The Early Development of Clinical Governance: a survey of NHS trusts in the West Midlands. Birmingham: health services Box 1: Research methods and data sources A survey of all trusts in the West Midlands was carried out in mid-1999.

3Research visits to all 47 trusts in the region were made in 1999 and 2000, during which key individuals at each organisation were interviewed, including chief executives, medical and nursing directors, clinical governance leads and non-executive directors. A total of 151 interviews took place.

Further follow-up telephone interviews with clinical governance leads at trusts were carried out, and interviews were also undertaken with 12 members of the NHS Executive regional office clinical governance visiting team.

Documents such as clinical governance strategies, plans, reports, and other papers were collated from trusts. Interviews were confidential, used a semi-structured interview schedule, were tape-recorded and were each undertaken by two researchers. Interview notes were made contemporaneously, and then transcribed.

The transcripts were coded and analysed to identify key themes and issues, using the Ethnograph software. We found strong support for the ideas, tempered by some caution about the problems involved in translating those ideas into reality. Importantly, we found that chief executives and senior clinicians saw these reforms as distinctively different from past quality initiatives in the NHS, because of their ambition, breadth and scope (see box 2).